Scolaris Content Display Scolaris Content Display

Study flow diagram.
Figures and Tables -
Figure 1

Study flow diagram.

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.
Figures and Tables -
Figure 2

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
Figures and Tables -
Figure 3

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 1 Health‐related quality of life (< 1 year).
Figures and Tables -
Analysis 1.1

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 1 Health‐related quality of life (< 1 year).

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 2 Health‐related quality of life (1 to 5 years).
Figures and Tables -
Analysis 1.2

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 2 Health‐related quality of life (1 to 5 years).

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 3 GORD‐specific quality of life (< 1 year).
Figures and Tables -
Analysis 1.3

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 3 GORD‐specific quality of life (< 1 year).

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 4 GORD‐specific quality of life (1 to 5 years).
Figures and Tables -
Analysis 1.4

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 4 GORD‐specific quality of life (1 to 5 years).

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 5 Serious adverse events.
Figures and Tables -
Analysis 1.5

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 5 Serious adverse events.

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 6 Adverse events.
Figures and Tables -
Analysis 1.6

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 6 Adverse events.

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 7 Dysphagia (< 1 year).
Figures and Tables -
Analysis 1.7

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 7 Dysphagia (< 1 year).

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 8 Dysphagia (1 to 5 years).
Figures and Tables -
Analysis 1.8

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 8 Dysphagia (1 to 5 years).

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 9 Dysphagia (5 years or more).
Figures and Tables -
Analysis 1.9

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 9 Dysphagia (5 years or more).

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 10 Heartburn (< 1 year).
Figures and Tables -
Analysis 1.10

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 10 Heartburn (< 1 year).

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 11 Heartburn (1 to 5 years).
Figures and Tables -
Analysis 1.11

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 11 Heartburn (1 to 5 years).

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 12 Heartburn (5 years or more).
Figures and Tables -
Analysis 1.12

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 12 Heartburn (5 years or more).

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 13 Reflux (< 1 year).
Figures and Tables -
Analysis 1.13

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 13 Reflux (< 1 year).

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 14 Reflux (1 to 5 years).
Figures and Tables -
Analysis 1.14

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 14 Reflux (1 to 5 years).

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 15 Reflux (5 years or more).
Figures and Tables -
Analysis 1.15

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 15 Reflux (5 years or more).

Summary of findings for the main comparison. Laparoscopic fundoplication versus medical management for gastro‐oesophageal reflux disease (GORD) in adults

Laparoscopic fundoplication versus medical management for gastro‐oesophageal reflux disease (GORD) in adults

Patient or population: Patients with gastro‐oesophageal reflux disease (GORD) in adults
Settings: Secondary care
Intervention: Laparoscopic fundoplication

Control: Medical management

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Medical management

Laparoscopic fundoplication

Health‐related quality of life

(< 1 year)

The mean health‐related quality of life (< 1 year) in the intervention groups was
0.14 standard deviations higher
(0.02 lower to 0.3 higher)

605
(3 studies)

⊕⊝⊝⊝
very low1,2,3

SMD 0.14 (‐0.02 to 0.3)

(1 to 5 years)

The mean health‐related quality of life (1 to 5 years) in the intervention groups was
0.03 standard deviations higher
(0.19 lower to 0.24 higher)

323
(2 studies)

⊕⊝⊝⊝
very low1,2,4

SMD 0.03 (‐0.19 to 0.24)

GORD‐specific quality of life

(< 1 year)

The mean GORD‐specific quality of life (< 1 year) in the intervention groups was
0.58 standard deviations higher
(0.46 to 0.7 higher)

1160
(4 studies)

⊕⊕⊝⊝
low1

SMD 0.58 (0.46 to 0.7)

(1 to 5 years)

The mean GORD‐specific quality of life (1 to 5 years) in the intervention groups was
0.28 standard deviations higher
(0.27 lower to 0.84 higher)

994
(3 studies)

⊕⊝⊝⊝
very low1,2,3

SMD 0.28 (‐0.27 to 0.84)

Adverse events

Serious adverse events

124 per 1000

181 per 1000
(125 to 262)

RR 1.46
(1.01 to 2.11)

637
(2 studies)

⊕⊝⊝⊝
very low1,5

Adverse events

10 per 1000

140 per 1000
(8 to 1000)

RR 13.98
(0.82 to 237.07)

83
(1 study)

⊕⊝⊝⊝
very low1,3,5,6

Dysphagia

(< 1 year)

36 per 1000

129 per 1000
(69 to 241)

RR 3.58
(1.91 to 6.71)

637
(2 studies)

⊕⊝⊝⊝
very low1,6

(1 to 5 years)

19 per 1000

101 per 1000
(39 to 256)

RR 5.36
(2.1 to 13.64)

554
(1 study)

⊕⊝⊝⊝
very low1,6

(5 years or more)

255 per 1000

229 per 1000
(145 to 361)

RR 0.9
(0.57 to 1.42)

228
(1 study)

⊕⊝⊝⊝
very low1,3,6

Heartburn

(< 1 year)

222 per 1000

100 per 1000
(67 to 153)

RR 0.45
(0.3 to 0.69)

554
(1 study)

⊕⊝⊝⊝
very low1,6

(1 to 5 years)

222 per 1000

42 per 1000
(22 to 75)

RR 0.19
(0.1 to 0.34)

554
(1 study)

⊕⊝⊝⊝
very low1,6

(5 years or more)

736 per 1000

412 per 1000
(324 to 530)

RR 0.56
(0.44 to 0.72)

217
(1 study)

⊕⊝⊝⊝
very low1,6

Reflux

(< 1 year)

199 per 1000

20 per 1000
(10 to 48)

RR 0.1
(0.05 to 0.24)

554
(1 study)

⊕⊝⊝⊝
very low1,6

(1 to 5 years)

139 per 1000

21 per 1000
(8 to 49)

RR 0.15
(0.06 to 0.35)

554
(1 study)

⊕⊝⊝⊝
very low1,6

(5 years or more)

357 per 1000

246 per 1000
(164 to 367)

RR 0.69
(0.46 to 1.03)

233
(1 study)

⊕⊝⊝⊝
very low1,3,6

Long‐term overall health‐related quality of life and long‐term GORD‐specific quality of life were not reported in any of the trials.

*The basis for the assumed risk was the mean control group risk across studies for all outcomes other than adverse events. For control group risk, 1% was used as the control group risk since there were no adverse events in the control group in the only trial that reported this outcome (Anvari 2011). The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio;

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 The trial(s) was/were at high risk of bias.
2 There was substantial heterogeneity.
3 The confidence intervals overlapped no effect and 25% or more increase or 25% or more decrease or both.
4 There were fewer than 400 participants in both groups.
5 Some trials did not report this outcome although this can be expected to be reported in a randomised controlled trial of laparoscopic fundoplication versus medical treatment.
6 There were fewer than 300 events in total in both groups.

Figures and Tables -
Summary of findings for the main comparison. Laparoscopic fundoplication versus medical management for gastro‐oesophageal reflux disease (GORD) in adults
Comparison 1. Laparoscopic fundoplication versus medical management

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Health‐related quality of life (< 1 year) Show forest plot

3

605

Std. Mean Difference (IV, Fixed, 95% CI)

0.14 [‐0.02, 0.30]

2 Health‐related quality of life (1 to 5 years) Show forest plot

2

323

Std. Mean Difference (IV, Fixed, 95% CI)

0.03 [‐0.19, 0.24]

3 GORD‐specific quality of life (< 1 year) Show forest plot

4

1160

Std. Mean Difference (IV, Fixed, 95% CI)

0.58 [0.46, 0.70]

4 GORD‐specific quality of life (1 to 5 years) Show forest plot

3

994

Std. Mean Difference (IV, Random, 95% CI)

0.28 [‐0.27, 0.84]

5 Serious adverse events Show forest plot

2

637

Risk Ratio (M‐H, Fixed, 95% CI)

1.46 [1.01, 2.11]

6 Adverse events Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

7 Dysphagia (< 1 year) Show forest plot

2

637

Risk Ratio (M‐H, Fixed, 95% CI)

3.58 [1.91, 6.71]

8 Dysphagia (1 to 5 years) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

9 Dysphagia (5 years or more) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

10 Heartburn (< 1 year) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

11 Heartburn (1 to 5 years) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

12 Heartburn (5 years or more) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

13 Reflux (< 1 year) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

14 Reflux (1 to 5 years) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

15 Reflux (5 years or more) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

Figures and Tables -
Comparison 1. Laparoscopic fundoplication versus medical management